Hodi et al found “encouraging survival outcomes” with the addition of nivolumab to ipilimumab in patients with previously untreated unresectable stage III or IV melanoma, according to 2-year overall survival data in the phase II CheckMate 069 trial. These results were reported in The Lancet Oncology.
Study Details
In the double-blind trial, 142 patients from 19 centers in the United States and France were randomized 2:1 between September 2013 and February 2014 to receive nivolumab (Opdivo) at 1 mg/kg plus ipilimumab (Yervoy) at 3 mg/kg (n = 95) vs ipilimumab at 3 mg/kg plus placebo (n = 47) every 3 weeks for 4 doses; then patients in the groups received nivolumab at 3 mg/kg vs placebo every 2 weeks until disease progression or unacceptable toxicity. A previous report on the primary endpoint of the study showed a higher objective response rate with the combination in patients with BRAF V600 wild-type melanoma. The current report is on the exploratory endpoint of overall survival.
Survival Outcomes
At median follow-up of 24.5 months, 2-year overall survival was 63.8% (95% confidence interval [CI] = 53.3%–72.6%) in the combination group vs 53.6% (95% CI = 38.1%–66.8%) in the ipilimumab group. Median overall survival was not reached in either group (hazard ratio = 0.74, P = .26).
Adverse Events
Treatment-related grade 3 or 4 adverse events were reported in 54% vs 20% of patients, with the most common being colitis (13%) and increased alanine transaminase levels (11%) in the combination group and diarrhea (11%) and hypophysitis (4%) in the ipilimumab group. Serious grade 3 or 4 treatment-related adverse events were reported in 36% vs 9%, including colitis (11%) and diarrhea (5%) in the combination group and diarrhea (4%) in the ipilimumab group. This updated analysis identified no new safety signals.
The investigators concluded: “Although follow-up of the patients in this study is ongoing, the results of this analysis suggest that the combination of first-line nivolumab plus ipilimumab might lead to improved outcomes compared with first-line ipilimumab alone in patients with advanced melanoma. The results suggest encouraging survival outcomes with immunotherapy in this population of patients.”
The study was funded by Bristol-Myers Squibb.
F. Stephen Hodi, MD, of Dana-Farber Cancer Institute, is the corresponding author of The Lancet Oncologyarticle.
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